臨床研究等提出・公開システム

Functional Electronic Stimulated Rehabilitation Application for Treatment in patients with cerebrovascular disorders

FRAT Study

10

1. Within 1 month of cerebrovascular event (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage) 2. With upper limb Brunnstrom stage(BRS)2-4 3. Who are 20 years of age or older at the time of obtaining informed consent

First patient in: Mar/14/2022 Last patient out: Oct/6/2023

No adverse events

Primary Outcome(s) Change in the amount of upper limb Fugl-Meyer Assessment(FMA)with respect to pre-intervention value at week 2 or at the time of discontinuation Secondary Outcome(s) 1.Changes in the amount of Functional Independence Measure(FIM)with respect to pre-intervention value at the 2nd and 4th weeks 2.Changes in the amount of upper limb BRS with respect to pre-intervention value at the 2nd and 4th weeks 3.Changes in the amount of upper limb FMA with respect to pre-intervention value at the 1st, 3rd, and 4th weeks 4.Changes in the amount of Barthel Index(BI)with respect to pre-intervention value at the 2nd and 4th weeks 5.Changes in grip strength with respect to the preintervention value at the 1st, 2nd, 3rd, and 4th weeks 6.Changes in the amount of upper limb Manual Muscle Test(MMT)with respect to pre-intervention value at the 1st, 2nd, 3rd, and 4th weeks

This clinical study on rehabilitation treatment using IVES was conducted, but the number of target patients was small and the planned number of cases could not be met. No adverse events occurred during the study period, suggesting safety. The average value calculated in this study exceeded 3.0, the estimated change with standard treatment, suggesting that it is effective in improving motor paralysis.

Oct. 31, 2025

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs052210163

Kobayashi Yasuyo

Nara Medical University Hospital

840 Shijo-cho Kashihara-shi Nara,Japan

tyasuyo@naramed-u.ac.jp

Kobayashi Yasuyo

Nara Medical University Hospital

840 Shijo-cho Kashihara-shi Nara,Japan

+81-744-22-3051

tyasuyo@naramed-u.ac.jp

Complete

Feb. 01, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Within 1 month of cerebrovascular event (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage)
2. With upper limb Brunnstrom stage(BRS)2-4
3. Who are 20 years of age or older at the time of obtaining informed consent
4. Whose consent to participate in this clinical study and the informed consent of the patient have has been obtained in writing

1. Received treatments, such as botulinum therapy, repeated transcranial magnetic stimulation, transcranial direct current stimulation within 90 days of obtaining consent
2. With a history of surgery(including device therapy)or intravenous t-PA for cerebrovascular event (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage)
3.Cognitive decline(Mini-Mental State Examination(MMSE)is 21 or less)
4.Severe skin symptoms on the affected upper limb
5.Have a history of epileptic seizures
6.With a history of substance abuse or addiction(including alcoholism)at the time of enrollment and within the past year, or patients with complications
7.Using an implantable cardiac stimulator such as a cardiac pacemaker or an implantable assisted heart
8.Using deep brain stimulation
9.With metal(excluding titanium products)implanted in the affected upper limb
10.Who are pregnant or may become pregnant
11.Who are judged by doctors to be inappropriate as research subjects

Both

Cerebrovascular disease

Rehabilitation using IVES+ for 20 minutes per day

Cerebrovascular disease , Rehabilitation

Change in the amount of upper limb Fugl-Meyer Assessment(FMA)with respect to pre-intervention value at week 2 or at the time of discontinuation

1.Changes in the amount of Functional Independence Measure(FIM)with respect to pre-intervention value at the 2nd and 4th weeks
2.Changes in the amount of upper limb BRS with respect to pre-intervention value at the 2nd and 4th weeks
3.Changes in the amount of upper limb FMA with respect to pre-intervention value at the 1st, 3rd, and 4th weeks
4.Changes in the amount of Barthel Index(BI)with respect to pre-intervention value at the 2nd and 4th weeks
5.Changes in grip strength with respect to the pre-intervention value at the 1st, 2nd, 3rd, and 4th weeks
6.Changes in the amount of upper limb Manual Muscle Test(MMT)with respect to pre-intervention value at the 1st, 2nd, 3rd, and 4th weeks

+81-744-29-8835

Nov. 16, 2021

none